According to a press release from Savara Pharmaceuticals, Phase II studies of the first effective and safe inhaled antibiotic designed to treat patients with cystic fibrosis and lung infection caused by methicillin-resistant aureus SARM.

AeroVanc is a dry powder dosage form of vancomycin for inhalation. Vancomycin has long been used intravenously for the treatment of infections caused by Gram-positive pathogens, including MRSA. The inhaled form of vancomycin reduces the amount of MRSA in the sputum, improves lung function, reduces the severity of respiratory symptoms and increases the time to the next exacerbation and the need for other antibiotics.

A randomized, double-blind, placebo-controlled study included 87 patients with cystic fibrosis and persistent lung infection with MRSA. The study evaluated the safety and efficacy of two different doses of inhaled vancomycin (32 mg and 64 mg), which were prescribed 2 times a day for 28 days.

The inhaled form of vancomycin, which is released as a dry powder from the capsule using a special device used by patients alone (without outside help), eliminates the poor penetration of the drug into the lungs and the phenomena of systemic toxicity which limits the use of vancomycin intravenously as a medicine for long-term treatment.

Higher concentrations of vancomycin at the site of infection by direct administration to the lungs may increase the clinical efficacy of antibiotic therapy.

The most frequently reported adverse event during the study was coughing, and there was no difference in the frequency of this adverse event between 2 doses of the drug and the placebo group. Symptoms of bronchial obstruction were more commonly seen in the group of patients receiving inhaled vancomycin at a dose of 64 mg.

All strains isolated from MRSA were susceptible to vancomycin. The researchers noted that there was no change in the BMD of vancomycin during and after treatment.

Over the past decade, the prevalence of MRSA has increased dramatically, but so far there has been no effective inhalation medication that can be used for a long time. Based on a successful Phase II clinical study, Savara Pharmaceuticals believes that AeroVanc can successfully treat MRSA infection in patients with cystic fibrosis and will be comparable in efficacy and safety to the antibiotic currently available inhaled effective against Pseudomonas aeruginosa.